India’s medical device manufacturers are being urged to step up adverse event reporting, as the Indian Pharmacopoeia Commission (IPC) directs marketing authorization holders to promptly flag all device-related incidents, citing ongoing underreporting by domestic firms. The IPC has instructed companies to report both serious and non-serious events, whether expected or unexpected, through the government’s Materiovigilance Programme of India (MvPI). The move aims to strengthen patient safety and improve national surveillance data.
The directive follows the recall of Johnson & Johnson’s hip replacement device in India after global concerns over metal toxicity and high failure rates. In a recent communication, IPC Secretary-cum-Scientific Director V Kalaiselvan emphasized that adverse event reporting is not just a regulatory obligation but a core element of patient safety. Despite simplified…
